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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. TKA FORCE BALANCER STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. TKA FORCE BALANCER STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 164206
Device Problems Fracture (1260); Device Difficult to Setup or Prepare (1487)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluation is anticipated but not yet begun. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Pin has fallen out on the tension er. Case type: tka. Update: "was the patient under anesthesia? no".
 
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Brand NameTKA FORCE BALANCER
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8975565
MDR Text Key156929033
Report Number3005985723-2019-00657
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number164206
Device Catalogue Number164206
Device Lot NumberERDNJ7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/09/2019 Patient Sequence Number: 1
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